IRB Analyst

Copernicus Group Independent Review Board - Cary, NC (30+ days ago)


Since 1996, Copernicus Group Independent Review Board®: (Copernicus IRB) has been the foremost provider of high-quality ethical review services, focused on the protection of human subject research, during all stages of clinical trials. Renowned for the relentless pursuit of efficiency, Copernicus IRB is incomparably organized to meet the demands of the industry and consistently delivers the most streamlined and highest quality review services to its clients.

The IRB Analyst: at our Cary, NC location will provide oversight and management of new protocol submissions from clients for IRB board review. As a liaison between the clients and the Company, advise sponsors, CROs and sites on regulatory compliance on IRB submissions. Within the scope of this position, contribute to the company’s overall mission to protect the rights and welfare of human subjects involved in clinical research.

ESSENTIAL DUTIES/RESPONSIBILITIES:
  • Act as the company representative to clients on initial study submissions and related information
  • Act as the liaison between IRB Board, CROs, sponsors, and Principal Investigator with initial study related information
  • Provide excellent customer service to all staff and/or Board members for project-related inquiries and/or needs
  • Work toward 100% accuracy in their work and understand the importance of accurate information as it pertains to strict confidentiality standards of the company
  • Ensure clients have all information they need regarding the new submission of their study including handling inquiries and providing timely follow up
  • Review new study applications and ensure they are complete and accurate according to internal standards
  • Enter new study information into Access database or other Business Systems as designated by the corporation
  • Prepare IRB agendas and prepare/distribute agenda items for IRB review
  • Prepare master set of minutes from Board meetings for other team member’s individual sets
  • Attend IRB meetings and take notes on agenda items and discussions
  • Prepare minutes for agenda items from Board Meeting
  • Ensure the thorough transition of reviewed studies throughout Client Services team communicating special cases and the needs of each study
  • Interpret and provide guidance to clients on IRB operating practices and procedures
  • Recommend actions to client inquiries regarding regulatory compliance with IRB regulations
  • Stay abreast of changes in regulations and companywide processes to be a reliable resource to clients in the new study phase
  • Coordinates with counterparts across the WIRB-Copernicus Group companies
EDUCATION REQUIREMENTS:
  • Bachelor’s degree or equivalent experience
QUALIFICATIONS/EXPERIENCE:
  • Minimum one-year experience in clinical trial setting, review board and/or pharmaceutical industry
  • Knowledge of FDA and OHRP regulations as they relate to research
  • Attention to detail required in a highly regulated industry
  • Ability to work independently, utilize independent judgment and discretion with respect to decision-making, and be a pro-active team player is required
  • Must possess excellent verbal and written communication skills
  • Medical terminology preferred
  • Must have advanced knowledge of Microsoft Word, Excel, Outlook and Access
WCG is proud to be an equal opportunity employer – : Qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, sexual orientation, gender identity, age, marital status, disability, veteran status or any other status protected by law.